Trials Sponsors Conditions Drugs Pricing

Conditions

Head and Neck Cancer

Keywords

head and neck cancergene therapystem cell therapyimmunotherappy

Outcome Measures

Primary Outcomes (1)

MTD after GX-051 intratumoral injection
2 months

Secondary Outcomes (6)

Adverse events after GX-051 intratumoral injection
2 months
Anti-tumor response by RECIST 1.1 on computed tomography
2 months
Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection
2 months
Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection
2 months
Evaluation of antibody generation against IL-12 which is active ingredient of GX-051
2 months
+1 more secondary outcomes

Study Arms (1)

GX-051

EXPERIMENTAL

GX-051 intratumoral injection

Biological: GX-051

Interventions

GX-051Biological

intratumoral injection

GX-051

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF).
Very advanced head and neck cancer aged more than 19.

Sponsors & Collaborators

Genexine, Inc.
Industrylead

Study Sites (1)

Seoul St.Mary's Hospital of the Catholic University of Korea

Seoul, 137-701, South Korea

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

Minsik Kim, M.D.
Seoul St.Mary's Hospital of the Catholic University of Korea
PRINCIPAL INVESTIGATOR
Hyun-Tak Jin, ph.D.
Genexine, Inc.
STUDY DIRECTOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 5, 2014

Study Start

March 2014

Date type not reported

This date has not been verified as actual or estimated.

Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

GX-051

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

GX-051

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations